Sodium-Glucose Cotransporter-2 Inhibitor for Patients With Acute Cardiorenal Syndrome
Yale University · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT07273838
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–85 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 2
- Target enrollment
- 130
- US sites recruiting
- 2
- Study start
- March 5, 2026
- Record last updated
- March 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The overall objective of this study is to determine whether the addition of SGLT2 inhibitors to usual care in hospitalized patients with heart failure associated acute kidney injury is safe and efficacious. Investigators will assess if SGLT2 inhibition improves a composite cardio-renal outcome (mortality, dialysis, AKI progression, decongestion metrics, heart failure symptoms). Secondary objectives of this study are to compare individual components of the composite outcome as well as changes in biomarkers of kidney injury, inflammation, repair and oxidative stress between those exposed to the SGLT2 inhibitor vs placebo.
Being studied: Dapagliflozin 10mg Tab; Placebo
Conditions: Heart Failure; Acute Kidney Injury
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥ 18 and ≤ 85 years-old
- Diagnosed with heart failure of either preserved or reduced left ventricular function
- Have signs of heart failure exacerbation
- Ability to take an oral medication
- Willing to adhere to the SGLT2i vs placebo regimen
Exclusion Criteria
- AKI can be primarily explained by another etiology
- Current use of SGLT2 inhibitor or exposure in the past 72 hours
- Pregnancy or lactation (pregnancy test prior to enrollment in women of child-bearing age)
- Known allergic reactions to components of an SGLT2 inhibitor
- Treatment with another investigational drug for heart failure different from or in addition to usual care within the 72 hours preceding AKI
- Any individual who meets any of the following criteria will be excluded from participation in this study:
- Documented history of ileal conduit (neobladder)
- No means of collecting urine such as patients with documented incontinence without indwelling or external urinary catheter
- Advanced kidney disease at baseline defined as baseline eGFR \< 25 ml/min/1.73m2
- Unexplained hypoglycemia in the past 30 days from enrollment
- History of Fournier's gangrene (pelvic necrotizing fasciitis)
- History of recurrent urinary tract infection (UTI): defined as documented UTI at least 2x in the preceding 6 months or 3 x in the preceding 12 months
- End-stage kidney disease with dialysis requirement
- Oliguria: defined as less than 30 ml urine output per hour for more than two consecutive hours or less than 500 ml over the preceding 24 hours
- Severe acute kidney injury with indications for dialysis
- Current dialysis receipt for acute kidney injury
- Comfort measures only
- Solid organ transplant on immunosuppression
Recruiting US locations
Yale New Haven Hospital-St. Raphael Campus
New Haven, CT 06510
Site contact: Abinet Aklilu, MD
Yale New Haven Hospital
New Haven, CT 06510
Site contact: Abinet Aklilu, MD
Study contacts (from the official record)
- Abinet Aklilu, MD · 203-931-5064 · abinet.aklilu@yale.edu
- Francis Wilson · francis.p.wilson@yale.edu
Similar studies in Connecticut
All heart & blood pressure studies in Connecticut →- Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
Impulse Dynamics
- Location
- Danbury, CT + 64 other US sites
- Eligibility basics
- Ages 18+
- RecruitingPhase 2
A Clinical Trial of MK-7262 and Enlicitide in Participants With High Lipoprotein(a) (MK-7262-004)
Merck Sharp & Dohme LLC
- Location
- Waterbury, CT + 23 other US sites
- Eligibility basics
- Ages 18+
- RecruitingPhase 3
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin
AstraZeneca
- Location
- Bridgeport, CT + 151 other US sites
- Eligibility basics
- Ages 40+
- RecruitingPhase 3
CLEOPATTRA: A Research Study to Look at the Effects of Treatment With a Medicine Called Coramitug (NNC6019-0001) in People With Heart Failure Due to Transthyretin Amyloid (ATTR) Amyloidosis
Novo Nordisk A/S
- Location
- New Haven, CT + 58 other US sites
- Eligibility basics
- Ages 18+